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On September 19, 2012, the Massachusetts Department of Public
Health ("DPH") amended the Pharmaceutical and Medical
Device Manufacturer Code of Conduct regulations (the "Code of
Conduct"). The amended regulations modify the obligations of
pharmaceutical and medical device manufacturers by: (1)
implementing recent changes to the governing statute; (2) eliminating certain
disclosure requirements; and (3) clarifying manufacturer
obligations with respect to registration and reporting
non-compliance.
The revised Code of Conduct relaxes certain restrictions on
interactions between manufacturers and health care
practitioners.
Meals in Connection with Educational
Presentations. Manufacturers may now provide "modest
meals and refreshments" to health care practitioners
outside the office or hospital setting if: (1) the food or
drink is provided in connection with educating or informing the
health care practitioners about a drug or medical device product,
disease states or other scientific information; and (2)
any such communications occur in a venue and manner conducive to
informational communication. In order to provide the food or drink,
manufacturers must also agree to quarterly reports detailing the
locations, products discussed, and the associated total and
per-participant expenditures. Significant ambiguities remain:
"Modest meals and refreshments" are defined as food
or drinks that "as judged by local standards, are similar to
what a health care practitioner might purchase when dining at his
or her own expense." This definition creates a potentially
variable standard. By contrast, many manufacturers have established
and seek to apply uniform meal limits that reflect general
standards regarding modest meals.
A "venue ...conducive to informational communication"
remains undefined.
The full scope of educational and informational presentations
that would support a meal outside an office or hospital
setting is not clear. The new disclosure requirements suggest that
the presentations must be educational presentations (other than
continuing medical educational presentations) rather than simply
informal communications (regardless of whether educational for the
health care practitioner).
These ambiguities will hopefully be resolved by DPH through
clarifying guidance.
Product Training Expenses. Manufacturers may
now pay the reasonable expenses incurred by health care
practitioners when participating in technical training in medical
device use without the need to include the obligation to pay
the expenses in a written purchase agreement.
The revised Code of Conduct would also phase out manufacturer
reporting obligations. After calendar year 2012, manufacturers
would no longer have to collect and report payments of $50 or more
to health care practitioners and health care providers, as is
currently required. A manufacturer would also be deemed to comply
with the new quarterly reporting requirements on meals provided
outside an office or hospital setting if the manufacturer made all
the disclosures required under the Federal Sunshine Law to the U.S.
Department of Health and Human Services ("HHS") (which
are then provided to DPH by HHS).
The revised Code of Conduct also expressly states that
manufacturers must annually register and pay the annual
registration fee. The revisions further require manufacturers to
self-report non-compliance with the Code of Conduct.
Because DPH issued the amendments as emergency regulations, the
new rules became legally effective immediately for a period of
three months. During that time, DPH must hold a public hearing in
order for the regulations to be permanently adopted. Following
public comment, DPH may revise the amendments, permanently publish
them as initially adopted, or allow the emergency regulations to
expire.
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guide to the subject matter. Specialist advice should be sought
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